The Company has created DNA-based compounds that in preclinical studies act as antagonists of TLR7 and TLR9, such as IMO-3100, or as antagonists of TLRs 7, 8, and 9, such as IMO-8400. The Company is developing IMO-3100, an antagonist of TLR7 and TLR9, for the treatment of psoriasis. It has selected IMO-8400, an antagonist of TLRs 7, 8, and 9, for development in the treatment of autoimmune diseases, with lupus as the initial disease indication. IMO-2055, a TLR9 agonist, is its lead drug candidate for the treatment of cancer. Clinical trials of IMO-2055 completed by the Company or by Merck KGaA include four Phase I clinical trials, of which two were in healthy subjects and two were in refractory cancer patients, and one Phase II clinical trial. The Phase II clinical trial was a monotherapy trial of IMO-2055 in patients with metastatic or recurrent clear cell renal cancer.
In preclinical animal models, the Company TLR7, 8, and 9 agonists have shown adjuvant activity when combined with various types of antigens. It has designed and created a new class of molecules to inhibit gene expression. These gene silencing oligonucleotides, which it refer to as GSOs, are nucleic acid-based and represent a novel approach to selectively, silence gene expression. It is actively engaged in preclinical research with its GSOs that is designed to explore their potential as research reagents and therapeutic agents. In addition to the Company’s clinical programs in autoimmune and inflammatory diseases and in cancer, it has identified TLR drug candidates for applications in the treatment of infectious diseases, respiratory diseases and hematological malignancies, and TLR3 agonists for use as vaccine adjuvants.
IMO-2125, a synthetic DNA-based TLR9 agonist, is its lead candidate for the treatment of chronic hepatitis C virus (HCV), infection. The Company conducted two Phase I clinical trials of IMO-2125 in patients with chronic HCV infection, one in patients with HCV who had not responded to prior treatment and one in combination with ribavirin, an antiviral medication approved for use in combination with interferon-alpha in the treatment of HCV infection, in treatment-naive patients with genotype 1 chronic HCV infection. In addition to the use of TLR9 agonists in oncology applications, it selected IMO-4200 as a lead TLR7 and TLR8 agonist candidate for the treatment of hematological cancers. Its TLR9 agonists are designed to induce immune responses that could be useful in restoring immune system balance. IMO-2134 is its lead TLR9 agonist for asthma and allergies. In addition to use of TLR7, 8, and 9 agonists as vaccine adjuvants, it also has created TLR3 agonists for potential use as vaccine adjuvants.
The Company competes with Dynavax Technologies Corporation, GlaxoSmithKline plc., Pfizer, Inc., VentiRx Pharmaceuticals., Novartis, Dynavax Technologies Corporation, VaxInnate, Inc., Intercell AG, Cytos Biotechnology AG and Celldex Therapeutics, Inc.